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A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

9. september 2026 opdateret af: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation

The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • Gainesville, Florida, Forenede Stater, 32607
      • Jacksonville, Florida, Forenede Stater, 32256
        • Ikke rekrutterer endnu
        • CNS Healthcare - Jacksonville (Clinical Neuroscience Solutions - Jacksonville)
        • Ledende efterforsker:
          • Jones
        • Kontakt:
      • Maitland, Florida, Forenede Stater, 32751
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70125
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02132
      • Watertown, Massachusetts, Forenede Stater, 02472
    • Missouri
      • Saint Charles, Missouri, Forenede Stater, 63304
        • Ikke rekrutterer endnu
        • St. Charles Psychiatric Associates/Midwest Research Group
        • Kontakt:
        • Ledende efterforsker:
          • Mattingly
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Ikke rekrutterer endnu
        • Center for Psychiatry and Behavioral Medicine. Inc.
        • Kontakt:
        • Ledende efterforsker:
          • Childress
    • New Jersey
      • Cherry Hill, New Jersey, Forenede Stater, 08002
    • New York
      • New York, New York, Forenede Stater, 10128
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45215
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
    • Texas
      • Austin, Texas, Forenede Stater, 78737
      • Bellaire, Texas, Forenede Stater, 77401
      • Houston, Texas, Forenede Stater, 77089
    • Washington
      • Everett, Washington, Forenede Stater, 98201

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

  1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).
  2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.
  3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.
  4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.

Exclusion Criteria

  1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.
  2. DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.
  3. Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.
  4. Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).
  5. In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).
  6. Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.
  7. Any disorder that is the primary focus of treatment other than ADHD.
  8. Evidence of current substance use disorder or history in the past 12 months.
  9. History of any prior exposure to centanafadine.
  10. Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.
  11. Have an allergy to the IMP or any component of the IMP.

Note: Other protocol-specified inclusion/exclusion criteria may apply.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Centanafadine XR
Participants will receive centanafadine XR capsule 328.8 milligrams (mg), orally, QD, for 8 weeks.
Medicin: Centanafadine XR
Oral capsules
Andre navne:
  • EB-1020

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) Total Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8

Sekundære resultatmål

Resultatmål
Tidsramme
Change From Baseline to Week 8 in the Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation (WRAADDS-ED) Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Clinical Global Impressions-Severity Scale for Attention-Deficit/Hyperactivity Disorder (CGI-S-ADHD) Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) T-score for the Global Executive Composite (GEC) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Behavioral Regulation Index (BRI) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the BRIEF-A T-score for the Metacognition Index (MI) Scale
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties in Emotion Regulation Scale (DERS) Total Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Nonacceptance of Emotional Responses (NONACCEPT) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Difficulties Engaging in Goal-Directed Behavior (GOALS) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Impulse Control Difficulties (IMPULSE) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Awareness (AWARE) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Limited Access to Emotion Regulation Strategies (STRATEGIES) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Lack of Emotional Clarity (CLARITY) DERS Subscale Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Change From Baseline to Week 8 in the Attention-Deficit/Hyperactivity Disorder Symptoms, Executive Function Deficits, and Emotional Dyscontrol as Assessed by the Adult ADHD Self-Report Scale (ASRS) Score
Tidsramme: Baseline up to Week 8
Baseline up to Week 8
Number of Participants With Adverse Events
Tidsramme: Up to Week 9
Up to Week 9
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Tidsramme: Up to Week 9
Up to Week 9

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2026

Primær færdiggørelse (Anslået)

27. maj 2027

Studieafslutning (Anslået)

27. maj 2027

Datoer for studieregistrering

Først indsendt

6. august 2026

Først indsendt, der opfyldte QC-kriterier

6. august 2026

Først opslået (Faktiske)

12. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 405-201-00231

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD-delingstidsramme

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD-delingsadgangskriterier

Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner